The Biostatistics and Data Management Core will facilitate the collection, tracking and processing of information for the Program Project Grant (PPG). It will provide the highest level of expertise in biostatistics for the design of the experiments and for formal presentations of significant experimental results. It will also provide support, development and maintenance of software and computer systems essential for the collection and analysis of data. Experimental designs are based on power analysis applied to Crossover or Latin Square models or a combination of both. Core personnel will maintain a continuing dialogue with project personnel on a regular basis to monitor data collection and processing and to modify experimental designs should new data and additional experiments warrant it. Extensive data management is already in place from previous PPGs and will be even more important in the renewal where more than 600 rats and 27 human subjects must be tracked, along with their experimental data. The Core will also provide education opportunities for graduate students in the Department of Biostatistics. The experiments proposed in the PPG provide real life examples of current statistical issues which will be addressed by graduate students under the supervision of the Biostatistics Faculty. Thus, the entire resources of the Biostatistics Department will be available to the PPG.